Brain Stimulation and Cognitive Training - Efficacy

University of Michigan

Status: Completed

Conditions: Schizophrenia; Bipolar Disorder; Schizo Affective Disorder

Treatments: Behavioral: BrainHQ; Device: tDCS (Inactive); Device: tDCS (Active)

Study type: Interventional

Funder types: Other

Identifiers

NCT05111548

HUM00119204b

Details and patient eligibility

About

People with serious mental illness often experience difficulties with thinking skills like memory. These difficulties can make it harder to perform day-to-day activities. The purpose of this study is to test whether combining a type of non-invasive brain stimulation with computerized cognitive exercises is helpful in improving a specific type of memory skill in people who have mental health conditions.

The study is a randomized clinical trial, meaning that participants will be randomly assigned to receive either 'active' or 'inactive' brain stimulation. All participants will complete computerized cognitive exercises, also known as cognitive training.

Overall, participants will be in the study for 6-8 weeks. The study involves 10 visits to the clinic over 2-4 weeks for cognitive training and either active or inactive brain stimulation. Participants will also complete paper-and-pencil assessments at the beginning and end of treatment, and one month after treatment ends.

Enrollment: 19 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of bipolar disorder I or II, schizoaffective disorder, or schizophrenia
• Willingness to participate in study procedures

Exclusion criteria

• History of neurological illness or injury (e.g., stroke)
• History of loss of consciousness
• Diagnosed intellectual disability
• Current substance use disorder
• Current mania or moderate depression or severe psychosis
• Current serious suicidal ideation/behavior
• Pregnant or trying to become pregnant, or currently lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

19 participants in 2 patient groups

Active stimulation + cognitive training

Experimental group

Description:

Participants receive 10 sessions of 'active' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).

Treatment:

Device: tDCS (Active)

Behavioral: BrainHQ

Inactive stimulation + cognitive training

Sham Comparator group

Description:

Participants receive 10 sessions of 'inactive' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).

Treatment:

Device: tDCS (Inactive)

Behavioral: BrainHQ